DSMI Clinical Specialist – Magazica Career Hub

Title: DSMI Clinical Specialist

Company: Bayshore HealthCare
Location: Mississauga, Ontario
Job Type: FlexTime, FullTime

Description:

The DSMI Clinical Specialist position involves addressing client follow-up queries, conducting follow-ups with various stakeholders, providing medical assessments, and ensuring accurate reporting of Adverse Events (AEs) and Follow-Up (FU) AEs. The role requires compliance with Canadian Adverse Event reporting guidelines, Good Pharmacovigilance Practices (GVP), and program-specific agreements. The ideal candidate will have a healthcare professional background and strong communication skills to engage effectively with Health Care Providers across Canada. Fluency in both English and French is required due to regular contact with colleagues and clients in different Canadian provinces.

Duties And Responsibilities

Address client follow-up queries promptly and professionally.

Identify missing or additional information and conduct systematic follow-ups with stakeholders.

Collaborate with internal teams to support timely submission of safety information.

Perform medical assessments of reported AEs and FU AEs.

Ensure timely submission of PV reports to clients and Health Canada.

Document all interactions in the safety database and maintain audit-ready records.

Participate in audits and inspections by providing accurate documentation.

Identify trends, data gaps, or process issues and contribute to improvement initiatives.

Support signal detection activities through trend analysis and safety evaluations.

General Duties And Responsibilities

Maintain confidentiality of patient, client, and corporate information.

Participate in Health and Safety activities.

Adhere to regulatory and contractual reporting requirements.

Complete other tasks as requested.

Qualifications

Degree/Diploma in Nursing, Pharmacy, or another healthcare-related field.

3-5 years of PV experience or related healthcare work experience.

Fluency in English and French.

Knowledge of Health Canada guidelines and PV regulations.

Strong attention to detail and ability to work under strict timelines.

Other Skills And Abilities

Excellent verbal and written communication skills.

Proficiency in PV databases and MS Office tools.

Ability to handle challenging conversations professionally.

Team player with the ability to function in a multi-disciplinary environment.

Primary Location ON-Mississauga

Apply Now

Magazica AI Resume Analyzer

Compare your resume with this job and get a personalized report.

⚠️ Please Sign in to use the Resume Analyzer.

🎤 Include Sample Interview Questions

Title: DSMI Clinical Specialist
Company: Bayshore HealthCare
Location: Mississauga, Ontario
Job Summary The DSMI Clinical Specialist is responsible for addressing client followup queries, conducting followups with multiple stakeholders  including reporters, patients, physicians, and pharmacies, providing medical assessments, and ensuring accurate reporting of Adverse Events (AEs) and FollowUp (FU) AEs. This role ensures compliance with Canadian Adverse Event reporting guidelines, Good Pharmacovigilance Practices (GVP), and programspecific agreements. The incumbent will represent the Pharmacovigilance Department at Bayshore Specialty Rx both internally and externally. The ideal candidate will have a healthcare professional background and strong communication skills to engage effectively with Health Care Providers across Canada.The candidate will be in regular/permanent contact with colleagues and clients in various Canadian provinces, therefore, fluency in both English and French is required.

Duties And Responsibilities Drug Safety &amp; Medical Information

Address client followup queries promptly and professionally.
 Identify missing or additional information in accordance with applicable regulatory requirements or internal SOPs, and conduct systematic follow ups with reporters, patients, physicians, pharmacies, and other stakeholders via phone, fax, or email within agreed service level timelines.
 Collaborate closely with internal teams to support timely submission of safety information and continuity of care.
 Perform medical assessments of reported AEs and FU AEs, including seriousness, expectedness, causality, and productevent relationship, ensuring clinical accuracy and completeness.
 Ensure timely submission of initial and followup PV reports to the pharmaceutical client orto Health Canada (MHPD) as per the program requirements and/or PV agreement.
 Document all followup interactions and assessments in the safety database, maintaining auditready records.
 Support reconciliation activities and source data verification as per PV agreements.
 Participate in audits and inspections by providing accurate followup documentation.
 Maintain a high level of customer service while building positive working relationship with HCP offices
 Identify trends, recurring data gaps, or process issues and contribute to continuous improvement initiatives within followup activities.
 Contribute to the development, review and continuous improvement of Pharmacovigilance SOPs to ensure ongoing regulatory compliance and operational effectiveness.
 Support signal detection activities through trend analysis, case clustering review and contribution to safety evaluations.

General Duties And Responsibilities

Maintain confidentiality of patient, client, and corporate information always.
 Participate in proactive Health and Safety activities while performing all duties.
 Is responsible to notify immediate Supervisor of any Health and Safety risks or concerns.
 Employee will maintain relevant level of knowledge of ICH (International Conference on Harmonization), GDP (Good Documentation Practices), GCP (Good Clinical Practice),Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines, andfamiliarity with Canada VigilanceMedEffect Program, as appropriate to their hired role which is to be provided at time of hire and on an as needed basis. With this knowledge the employee will perform the work as required by their assigned function and will be provided with regular updates as required.
 Participate in processes relating to regulatory and/or contractual reporting requirements.
 Adhere to Bayshore's Policies and Procedures.
 Complete other tasks as requested.

Qualifications EDUCATION

Degree/Diploma in Nursing, Pharmacy, or another healthcarerelated field (mandatory).
 Degree in a health or life sciences related field, professional advanced scientific degree preferred or equivalent combination of education and experience.

Experience

35 years of PV experience or related healthcare work experience (in Drug/Medical Information, Medical Affairs, Regulatory Affairs, Clinical Trials, or Healthcare call center environment).
 Must be fluent in verbal and written communication and interpersonal skills for both English and French. (Applicable for provinces/regions with French language service requirements)
 Prior experience in patient/HCP communication and case followup preferred.
 Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Global PV regulations, ICH guidelines and Pharmacovigilance auditing.
 Strong knowledge of drug benefit/risk profile, various disease states, internal medicine, physiology, toxicology, and pharmacology will be considered an asset.
 Knowledge of MedDRA terminology and coding conventions is considered an asset.

Other Skills And Abilities

Excellent verbal and written communication skills.
 Strong attention to detail and ability to work under strict timelines and handle multiple priorities.
 Proficiency in PV databases and MS Office tools.
 Ability to handle challenging conversations professionally.
 Team player with ability to function in a multidisciplinary environment.

Primary LocationONMississauga

I agree to the Resume Analyzer Terms & Conditions.

Magazica AI Resume Analyzer

Match Score: 0%

Disclaimer

Professional Advice

Company

SUBSCRIPTION